
Tenders & Public Procurement (Romania)
SEAP-ready documentation, compliant specifications, and disciplined bid execution—built for medical devices and regulated healthcare products.
What we support in Romania
Public procurement is documentation-first. We help you prepare a defensible, compliant tender package and execute the bid process with discipline.
SEAP tender preparation
- Tender mapping and route selection (direct purchase / simplified / open procedure as applicable)
- Document pack structure and submission plan
- Risk review: technical non-compliance, missing proofs, deadlines
Specifications & compliance checks
- Spec alignment to product IFU / technical documentation (no “marketing specs”)
- Clarifications strategy (questions, responses, evidence mapping)
- Consistency checks across forms, annexes, and declarations
Bid discipline & submission support
- Timeline and responsibilities (RACI)
- Final completeness checks (format, signatures, validity dates)
- Post-submission support: clarifications, document re-uploads where allowed
How it works
01 → 02 → 03 → 04 → 05
STEP 01
Tender intake & scope
- onfirm product type and tender target (hospital / authority / framework as applicable)
- Identify the compliance route and constraints (MDR/IVDR, national requirements, language)
- Build a deadline plan with document owners
Output: Tender scope + deadline plan
STEP 02
Tender scope + deadline plan
- Map tender requirements to product evidence (IFU, certificates, declarations, test reports)
- Identify gaps early and define fixes (or “no-bid” decision)
Output: Requirements-to-evidence matrix
STEP 03
Documentation pack build
Medical devices
- Assemble the submission pack (forms, declarations, certificates, translations where required)
- Harmonize naming conventions, validity dates, signatures, stamps (where applicable)
Output: Submission-ready document pack
STEP 04
SEAP submission support
- Final completeness and format checks
- Upload support + validation steps (where applicable)
Output: Submitted bid + audit trail checklist
STEP 05
Clarifications & follow-through
- Support clarifications with evidence-based responses
- Track decisions, appeal windows, and next steps
Output: Clarification response set + closeout note
Deliverables you receive
- Tender scope & timeline plan
- Requirements-to-evidence matrix
- Submission pack folder structure + naming convention
- Translation/localization checklist (if required)
- Compliance risk review (go/no-go)
- Final QA checklist (signatures, dates, formats)
- Clarifications response templates
- Post-submission tracking sheet
What we need to start
- SEAP link / tender ID (or draft RFQ)
- Product IFU + technical documentation pack
- CE certificates (where applicable) + DoC
- Company documents (registration, authorizations if relevant)
- Proposed pricing and delivery terms
- Contact person for manufacturer evidence (if needed)
Want a fast “SEAP readiness” check on your next tender?
FAQ
Yes. We support both direct purchases and competitive tender procedures in Romania. Where we act as the distributor, we can handle end-to-end tender execution once a distribution agreement is in place and the product can be legally placed on the Romanian market (including the relevant ANMDMR-related operator/product workflows, as applicable). For one-off projects, we can also support readiness and documentation packaging even if the contracting entity is different.
Yes. Supporting non-EU manufacturers is a core part of our model. We help structure the EU/Romania entry route (MDR/IVDR context where relevant), align documentation and labeling, and execute the Romania market-access steps needed for compliant supply. The exact setup depends on the product category and the economic-operator roles (manufacturer, authorised representative where applicable, importer, distributor), but we can guide and operationalise the process.
Yes. We coordinate Romanian-language readiness for market entry and procurement—typically including labeling/IFU and tender-facing documentation where required. Translation is handled with controlled terminology and consistency checks so the Romanian version remains aligned with the source technical documentation (this reduces tender risk and post-market misunderstandings).
The most common causes are administrative and documentation inconsistencies, not price. Typical issues include:
- missing/expired certificates or declarations
- discrepancies between the technical offer and the IFU/technical documentation
- incomplete forms, incorrect signatures/stamps (where required), or wrong file formats
- unclear evidence mapping to mandatory requirements
Our approach is to use a requirements-to-evidence matrix and a final QA checklist to prevent avoidable disqualifications.
Yes. We support post-submission clarifications by preparing evidence-based responses that remain consistent with the submitted offer and the product’s verified documentation. This includes rapid document retrieval, controlled wording, and clear mapping to the contracting authority’s questions—within the permitted timelines and procedural rules.

